Biosimilars have been at the center of attention in the U.S. healthcare world for more than a decade in the avatar of an alternate to the costly drugs at-hand.
Biosimilar, as an approach, came into the foray from the passing of Biologics Price Competition and Innovation Act (BPCI Act) in 2009. But, the road from being a concept into being a burgeoning stream of mainstream applicability has been marred by delays and slow acceptance. To put this in context of numbers, in the U.S., only 8 biosimilars have received the FDA approval seal, with 2 of these products currently in the market and the rest planned to be launched in the future.
The non-success of Biosimilars enmasse can be attributed to three factors:
- Payer adoption: A key winning proposition of Biosimilars when it was first conceptualized was the cost differentiator it would get to the market. The initial hurrah of wanting to rapidly introduce this to the larger market was the datum that Payers would be able to save substantially while procuring such alternatives from the manufacturers, which in-turn would result in consumers saving cost. Unfortunately, the current reality is far from this. Payers are unable to find the savings that they had presumed would be available due to high manufacturing costs. This has proved to be a major damper in the enthusiasm matrix of Payers wanting to adopt Biosimilars for a larger market in their formulary list.
- Acceptance by physicians: Biosimilars, as a concept, are purported to be substitutes of generic medications. Whilst the commonalities between Generics & Biosimilars are large, there are also distinctiveness between the two; e.g. - difference in chemical compositions. Providers & Physicians, though largely agree that Biosimilars can be Generic's substitute, the lack of wanting to prescribe this to manage population, stems from factors as – lack of trial & proven data of Biosimilar's effectiveness, clear reimbursement guidelines, associate failure cost of switching (Generic to Biosimilar), and potential legal consequences in the instance of deficiency due to Biosimilar-based treatment.
- Consumer readiness towards substitutes: Success of any product is dependent on the willingness of its consumers wanting to use it. Biosimilars are falling flat when measured against this metric due to consumers unwilling to try/continue Biosimilar-based treatments. The acceptance is low, primarily for the fact that people are not educated or aware about Biosimilars being an option. Also, for people who are aware about it, the literatures available do not substantiate all the benefits it can provide.
While there are no two ways about the fact that Biosimilars bring in a lot of advantage, success of this can be achieved when the Health industry works cohesively as against the individual efforts pursued today. Biosimilar manufactures will have to look at levelling costs and payers & providers will have to work closely towards not just building their internal confidence on its effectiveness, but also to start educating consumers about it to build their confidence on it.
AUTHOR: Karthik NS
Karthik is a Healthcare IT enthusiast with 12 years of work experience. He works as an Enterprise Business Analyst at EVRY India.